GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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Pre-ANDA Program Overview
Zhang, Lei
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Generic Drug Reflection Paper
Zhang, Lei
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Generic Drug Reflection Paper
Zhang, Lei
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Generic Drug Reflection Paper
Zhang, Lei
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FDA Research Update on the FY18 Initiatives
Zhang, Lei
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OGD Research Program
Yu, Lawrence
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Introduction to Q3
Yu, Lawrence
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Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
Frost, Mitchell
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Product-Specific Guidance Fundamentals from a Clinical Perspective
Frost, Mitchell
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Keynote: Non-traditional Approaches to Bioequivalence & Application of Clinical Pharmacology to Minimize Barriers to Generic Drug Substitution
Uhl, Kathleen